Classifications

• • G—PHYSICS
  • G01—MEASURING; TESTING
  • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
  • G01N1/00—Sampling; Preparing specimens for investigation
  • G01N1/02—Devices for withdrawing samples
  • G01N1/10—Devices for withdrawing samples in the liquid or fluent state
  • G01N1/12—Dippers; Dredgers
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/15—Devices for taking samples of blood
  • A61B5/150007—Details
  • A61B5/150015—Source of blood
  • A61B5/150022—Source of blood for capillary blood or interstitial fluid
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/15—Devices for taking samples of blood
  • A61B5/150007—Details
  • A61B5/150343—Collection vessels for collecting blood samples from the skin surface, e.g. test tubes, cuvettes

Definitions

• the present invention relates to a device for receiving a sample of liquid, and in particular, but not exclusively, to a device for receiving a sample of bodily liquid such as blood so that it can be subjected to an assay.
• the present invention provides a device for receiving a sample of liquid, comprising: a body having at least a major surface and a minor surface; a sample-receiving chamber located in the body and having an inlet end which opens into the major and minor surfaces of the body; and a conduit located in the body and extending from the outlet end of the chamber, the conduit being arranged so as to allow the liquid to pass from the outlet end into the conduit by capillary action.
• the present invention allows a user to deposit a liquid sample into or onto the device at the sample-receiving chamber.
• the user can remove the source of the sample (e.g. finger) and the device ensures that the liquid is supplied down the conduit, for example to allow an assay to be performed at another area of the device.
• This is important for diagnostic devices for blood samples where the assay result is not produced instantly, for example immunoassays requiring immunobinding of reagents to occur or biological enzyme reactions which link the measurement of blood clotting time. It is also important for devices where diagnosis or assay has to be carried out remote from the sample-receiving chamber.
• sample- receiving chamber acts as a liquid reservoir which is thereafter able to supply the rest of the device with sufficient liquid even in the absence of the user maintaining contact with the device and removes the need for the user to maintain constant contact with the device during the filling process. This is especially advantageous for older people who might find it difficult to maintain constant contact with a device which may be of small dimensions. Furthermore it reduces the possibility of device malfunction as removal of the liquid source at any time during filling may result in underfilling or the introduction of air bubbles.
• the chamber is useful for devices which have a filling time greater than the time taken for the user to merely present the source of liquid to the device and to then remove it, for example a filling time of one second or more.
• the device of the present invention may be a device for use in chemical (especially biochemical or clinical) test procedures, often known as a capillary fill test device.
• Capillary fill test devices are generally used in combination with a second device, typically an electronic instrument designed to detect the existence, or the extent of, a predetermined interaction of the liquid sample, or one or more analytes in the liquid sample, with one or more other components of the device.
• Such components may be an electrode structure and/or one or more fluid-interactive or analyte-reactive compositions.
• the electronic instrument may be used to assess the sample liquid in the device, most typically by photometric or electrometric techniques after a predetermined sample reaction period.
• Capillary fill devices are often designed to be positioned in the electronic instrument before the device is loaded with the fluid sample.
• the sample-receiving chamber When the capillary fill device is properly positioned in the instrument, the sample-receiving chamber is external to the instrument and accessible to the user, and the area of the device where analysis takes place is located in electrical or phototransmissive/photoreflective communication with a sensor element capable of detecting and reporting a condition or change of condition of the liquid after or during a predetermined time period.
• a volume of test liquid is delivered to the sample- receiving chamber to be drawn by capillary action (and possibly other forces) into and through the conduit and into the area of the device where analysis takes place.
• the instrument can be equipped with sensors to detect the flow of the test liquid through the conduit; optionally the instrument can be designed to use such detected flow to initiate a test sequence.
• the rate of flow of the liquid through the capillary flow conduit is sensed and used as a parameter in the test sequence.
• the conduit serves additionally to provide means for measuring flow characteristics, i.e., viscosity, of the test liquid as it is delivered to the test area.
• the body of the device may be a generally rectilinear strip, as is conventional for capillary test devices. Such strips may have end walls, side walls and/or top and bottom surfaces or parts thereof which are not parallel to each other. Alternatively, it may be cylindrical, wedge-shaped, disc-shaped, or any other convenient shape, provided that it has major and minor surfaces into which the inlet end of the sample- receiving chamber opens.
• the inlet end of the sample-receiving chamber opens into the major and minor external surfaces of the body.
• the major and minor surfaces may be generally perpendicular to each another, and the minor surface may have a significantly smaller surface area than the major surface.
• the minor surface may be an end or side wall and the major surface may be a top surface (when the body is a rectilinear strip or wedge- or disc-shaped for example). In such instances, the sides of the device cannot be considered to be major surfaces.
• the minor surface is an end wall and the major surface is an outer surface (when the body is cylindrical for example). Regardless of the shape of the body, the opening of the inlet end is preferably continuous in the major and minor surfaces.
• the portion of the sample-receiving chamber which opens into the minor surface may be less than the portion which opens into the major surface.
• the area of the chamber opening onto the major surface may be 1.3 to 3 times, in one embodiment 1.6 times, the area of the chamber opening into the minor surface.
• the sample-receiving chamber may taper from the inlet end to the outlet end, and may be generally V- or U-shaped.
• the width of the inlet end may be approximately 10-15 times the width of the outlet end, and may be 0.5-1.5 times the length of the sample-receiving portion.
• the conduit is arranged so as to allow the liquid sample to move by capillary action, although other forces can act on the liquid such as hydrostatic pressure and/or positive displacement to cause it to move along the conduit.
• the maximum dimension of the conduit may be less than 0.5, 0.4 or 0.3 mm. In one embodiment, the maximum dimension is in the range of from 0.25 to 0.3 mm and may be about 0.28 mm.
• the conduit may have a Reynolds number less than about 200, this number being calculated according to the formula: pVd
• Re Reynolds number
• p Fluid density
• V Fluid velocity
• d length scale
• ⁇ dynamic viscosity
• At least the sample-receiving chamber and the conduit are conveniently coated with a hydrophilic coating, which may be on any or all of the walls thereof.
• the coating may provide a contact angle of 90° or less, 30° or less, or 20° or less.
• the contact angle may be in the range of from 5 to 15° and may be 11 °. It may provide a contact angle of 110° provided that it is applied only on one wall.
• the contact angle may be determined as described at page 46 of "Fundamental and Applications of Microfiuidics", Nguyen & Werely, Artech House, 30 Sept 2002, ISBN 1580533434.
• the liquid to be sampled can be any liquid.
• the liquid is a bodily liquid, such as whole blood, plasma, interstitial fluid, cerebrospinal fluid (CSF), urine, serum, saliva, tears and sweat.
• CSF cerebrospinal fluid
• the present invention provides a device for receiving a sample of liquid, comprising: a body having at least an end wall; a generally V-shaped sample-receiving chamber located in the body and having an inlet end which opens into the end wall of the body; and a conduit located in the body and extending from the outlet end of the chamber, the conduit being arranged so as to allow the liquid to pass from the outlet end into the conduit by capillary action.
• the devices of the present invention may be used to receive blood which is subjected to the measurement of blood coagulation and/or other haemostasis measurements, such as prothrombin times. They may also be used in to receive bodily liquids which are subjected to immunoassays, hormone measurements, detection of cardiology markers, detection of cancer markers, detection of infectious disease agents, etc.
• Figure 1 is a partial isometric view of one embodiment of the invention
• Figure 2 is a plan view of the device of Figure 1;
• Figure 3 is a section along the line X-X in Figure 2;
• Figure 4 is an isometric view of a section along the line X-X in Figure 2;
• Figures 5a and b are plan views of two alternative embodiments of the invention.
• Figure 6 is a graph plotting fill time against the volume of whole blood added to a device in accordance with the present invention.
• Figure 7 is a partial isometric view of the front end of another embodiment of the invention.
• Figure 8 is a plan view of the device of Figure 7.
• Figure 9 is a section along line X-X in Figure 8.
• a device 1 is partially shown.
• Device 1 has a top (major) surface 2, and an end (minor) surface 3 and respective side surfaces 4. The bottom surface of the device cannot be seen.
• Device 1 tapers towards end surface 3. In some embodiments, device 1 does not have this taper and, in others, it has a hammerhead shape.
• a sample-receiving chamber 5 is recessed in the device 1 such that it opens into top surface 2 and end surface 3. In an alternative embodiment, sample-receiving chamber 5 opens into top surface 2 and a side surface 4.
• the sample receiving chamber 5 has an inlet end, and an outlet end which opens into a conduit 6.
• the inlet end is substantially larger than the outlet end such that the chamber 5 tapers towards to the outlet end in a V-shape.
• Alternative generally V- or U-shaped chambers are shown in Figures 5a and b.
• sample receiving chamber 5 tapers such that the dimension A decreases in value from the inlet end to the outlet end.
• the sample chamber may be of any shape and dimensions so long as a liquid sample is able to pass from the inlet end to the outlet end by capillary action.
• the shape and dimensions of the chamber may be chosen such that the capillarity at the outlet end is greater than the capillarity at the inlet end.
• conduit 6 is a channel recessed into the top surface 2.
• conduit 6 is closed by means of a laminar layer laid onto top surface 2.
• the layer may overlay all or a part of the sample-receiving chamber 5, although it is not preferred if it overlays all of sample-receiving chamber 5 because the additional friction provided by the layer over the chamber 5 reduces the speed at which liquid can travel down conduit 6.
• Partial overlay of the sample-receiving chamber 5 may be advantageous to break the surface tension of the sample as it is applied to the sample receiving chamber and aid entry of the sample into conduit 6. Partial overlay also allows for the addition of a sample volume that is larger than could be added to sample receiving chamber that is overlayed.
• the other end of conduit 6 leads to an area of the device where an analysis or assay of the liquid can be carried out (not shown).
• dimension A is 0.9 mm
• B is 2.5 mm
• C is 0.2 mm
• D is 3 mm
• E is 0.2 mm.
• Devices of the invention can be prepared using a variety of techniques known in the art. For example, injection moulding or microinjection moulding using suitable moulds can be used. Alternatively, embossing techniques where the structure is pressed into a material and techniques using silicon etching and/or photolithography can also be used.
• the device may be made by laminating two or more layers.
• such a device may comprise three layers.
• a base layer 7 forms the bottom surface of the chamber 5 and channel 6.
• a middle layer 8 has cuts therethrough to form the walls of the chamber 5 and channel 6.
• a top layer 9 forms the top surface of the channel 6.
• top layer 9 partially overlays the sample receiving chamber 5 that is formed by the cut sides of layer 8 and the top surface of base layer 7.
• a plan view of Figure 7 is shown in Figure 8 and a section along line X-X of Figure 8 is shown in Figure 9.
• dimension A is 0.275 mm
• B is 3 mm
• C is 0.3 mm
• D is 2.5 mm
• E is 0.175 mm
• F is 2 mm.
• a laminated device in accordance with the present invention may be made as described in UK Patent Application No. 0327094.9, the disclosure of which is incorporated by reference.
• Polystyrene devices were injection moulded with a sample-receiving chamber as shown in Figures 1-4. These devices were then treated with plasma enhanced chemical vapour deposition to coat the surface with a hydrophilic molecular layer such that the contact angle following treatment was approximately 11°. Techniques for doing this are well known to those skilled in the art. The devices were then laminated with a hydrophilic laminate (contact angle 11°) such that the laminate covered the conduit 6, but not the sample-receiving chamber 5.
• volume of 5 ⁇ l or less result in fill times of greater than about 20 seconds, and volumes of 7 ⁇ l or more have little effect on fill time.

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• Health & Medical Sciences (AREA)
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• General Health & Medical Sciences (AREA)
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• Animal Behavior & Ethology (AREA)
• Engineering & Computer Science (AREA)
• Biomedical Technology (AREA)
• Heart & Thoracic Surgery (AREA)
• Medical Informatics (AREA)
• Molecular Biology (AREA)
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• Public Health (AREA)
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• General Physics & Mathematics (AREA)
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• Dermatology (AREA)
• Investigating Or Analysing Biological Materials (AREA)
• Sampling And Sample Adjustment (AREA)
• Automatic Analysis And Handling Materials Therefor (AREA)

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• 2004
  • 2004-08-27 WO PCT/GB2004/003683 patent/WO2005020817A1/en active Application Filing
  • 2004-08-27 EP EP04768238A patent/EP1667581A1/en not_active Withdrawn
  • 2004-08-27 JP JP2006524423A patent/JP2007504438A/ja not_active Withdrawn
  • 2004-08-27 CA CA002537091A patent/CA2537091A1/en not_active Abandoned
  • 2004-08-27 AU AU2004268431A patent/AU2004268431A1/en not_active Abandoned
  • 2004-08-31 US US10/930,717 patent/US7305896B2/en active Active
• 2007
  • 2007-12-11 US US11/954,131 patent/US20080161769A1/en not_active Abandoned

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